subchapter_subject: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_code: "558"
part_subject: "NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS"
subpart_code: "A"
subpart_subject: "General Provisions"
section_number: "558.4"
section_subject: "Requirement of a medicated feed mill license."
cfr_reference: "21 CFR 558.4"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 500 to 599"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(a)A feed manufacturing facility must possess a medicated feed mill license in order to manufacture a Type B or Type C medicated feed from a Category II, Type A medicated article.
(b)The manufacture of the following types of feed are exempt from the required license, unless otherwise specified:
(1)Type B or Type C medicated feed using Category I, Type A medicated articles or Category I, Type B or Type C medicated feeds; and
(2)Type B or Type C medicated feed using Category II, Type B or Type C medicated feeds.
(c)The use of Type B and Type C medicated feeds shall also conform to the conditions of use provided for in subpart B of this part.
(d)This paragraph identifies each drug by category, the maximum level of drug in Type B medicated feeds, and the assay limits for the drug in Type A medicated articles and Type B and Type C medicated feeds, as follows:
(e)When drugs from both categories are in combination, the Category II requirements will apply to the combination drug product.
For Federal Register citations affecting § 558.4, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.